Bristol-Myers Squibb Company

Associate Director, Biostatistics, Innovative Medicines Development

Location
Princeton, NJ, US
Posted
Nov 27, 2018
Ref
R1511805
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Description and Responsibilities

This individual is a member of cross-functional development teams and will support Biostatistics TA Head of Immunoscience to provide expert and independent statistical leadership in support of the development of Tyk2 in Lupus (such as SLE and lupus nephritis), including guidance on statistical methods, appropriate study design, data analytical approaches and interpretation of results.
  • Support the Biostatistics TA Head to ensure execution of development strategy of Tyk2 with respect to development of indication-specific methodology, study designs, data collection, reporting and interpretation as well as regulatory and HTA interactions.
  • Develops an effective partnership with the Biostatistics Asset Leads (BAL) to ensure the team's ability to execute with quality in agreed to timelines. Provide statistical guidance/oversight to BAL at the strategic partner.
  • Demonstrate a high degree of knowledge regarding the asset including knowledge of the underlying disease(s) and potential mechanism(s) of action, as well as current treatment landscape, up-to-date scientific literature and issues related to regulatory submission history of related products. Utilize data mining techniques to explore historical data to enhance development strategy for Tyk2 in IBD.
  • Collaborate effectively with colleagues from multiple drug development functions by driving statistical thinking, and proper data interpretation.
  • Influence the broader organization with respect to innovation in clinical study design.

Position Requirements

Ph.D. (or equivalent) in Statistics or related field. Seven years or more in Pharmaceutical/R&D or other related experience, including supporting regulatory filings in multiple regions (e.g. US, EU, Japan). Experience in planning for & participating in regulatory meetings, (e.g. US FDA). Expertise in general & cutting edge statistical/clinical trials methodology & ability to apply to relevant clinical development framework. Demonstrated ability in solving complex statistical problems. Excellent verbal and written communications skills. Ability to work successfully in cross-functional teams leading to successful global regulatory filings and approvals. Strong communication/presentation skills with ability to tailor the message to the key stakeholder for effective impact and influence. Ability to be flexible and adapt quickly to the changing needs of the organization. Ability to organize multiple work assignments and establish priorities. Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs. Experience in development of compounds in Lupus preferred.